P1081 was a phase IV open-label randomized study of HIV-1 infected pregnant women who are ARV-naïve (except for ARVs for PMTCT in previous pregnancies) between 28 and 36 weeks gestation and their infants. Women are randomized to one of three different triple ARV regimens:

Arm A: lamivudine/zidovudine + lopinavir/ritonavir

Arm B: lamivudine/zidovudine + efavirenz

Arm C: lamivudine/zidovudine + raltegravir

Main Objectives:

To compare the ability to achieve both (a) a rapid viral load decrease (by week 2) which is sustained until delivery and (b) tolerability through delivery of three different triple ARV regimens (containing lopinavir/ritonavir, efavirenz or raltegravir) in pregnant women initiating triple ARV regimens between 28 and 36 weeks of gestation for PMTCT.

To evaluate the safety of the three regimens including adverse events that may occur while on study drug or during maternal and infant follow-up.